(102 days)
Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the Artis family include cardiac angiography, neuroangiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.
Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis Q and Artis Q.zen include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of twodimensional images acquired with a standard angiographic C-arm device into a threedimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
The Artis Q and Artis Q.zen Modular Angiography System is a further development of the Artis zee / zeego Modular Angiography System. It is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. New Flat Panel detectors, a new x-ray tube are implemented and system improvements were performed to the systems.
The Artis Q and Artis Q.zen Modular Angiography System is substantially equivalent to the Artis zee / zeego Modular Angiography System VC14 with all its components as described in the Device Description, Section 10 and the Substantial Equivalence Section 11.
This 510(k) submission (K123529) for the Siemens Artis Q and Q.zen Modular Angiographic System is a Special 510(k), indicating it's for a modification to a legally marketed device. Therefore, the submission primarily focuses on demonstrating that the modified device is substantially equivalent to its predicate device (Artis zee / zeego Modular Angiography System, K090745) and that the changes do not raise new questions of safety or effectiveness.
Special 510(k)s typically do not involve extensive new clinical studies to establish acceptance criteria for device performance. Instead, they often rely on verification and validation testing to ensure the modified device performs as intended and meets established safety and performance characteristics of the predicate device.
Therefore, much of the requested information (acceptance criteria, specific study details like sample sizes, expert involvement, and MRMC studies) is generally not provided or required for a Special 510(k) unless the modifications warrant new performance claims beyond those of the predicate.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical performance targets and reported device performance for the Artis Q and Q.zen. The focus is on demonstrating substantial equivalence to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As it's a Special 510(k) for a modified device, the submission likely relies on verification and validation testing, which might not involve a separate "test set" in the context of clinical performance evaluation in the same way a de novo or traditional 510(k) for a novel device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Ground truth establishment by experts is typically relevant for clinical performance studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for clinical performance studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not mentioned and is highly unlikely for this type of submission. This device is an angiographic system, not an AI-powered diagnostic tool, so "human readers improve with AI" is not a relevant concept for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to an angiographic system like the Artis Q and Q.zen. It's a medical imaging device operated by humans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. For a Special 510(k) focused on device modifications (new detectors, x-ray tube, system improvements), the "ground truth" would likely relate to engineering specifications, image quality metrics, and safety standards, rather than clinical outcomes or pathology from a patient cohort.
The document states: "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." This implies that the "ground truth" for demonstrating safety and effectiveness would be conformance to predefined engineering and safety specifications, validated through various tests.
8. The sample size for the training set
This information is not provided. This device is not an AI/ML product that would require a "training set" in that context. The "training" of the system refers to its design and manufacturing processes.
9. How the ground truth for the training set was established
This information is not provided and is not applicable in the context of an AI/ML training set. The "ground truth" for the device's development and manufacturing would be established through engineering design specifications, international standards, and regulatory requirements.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.